RELUGOLIX | N214621 | SUMITOMO PHARMA AMERICA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2025-08-01 | Active | — | |
Sumitomo Pharma Switzerland GmbH et al v. Aizant Drug Research Solutions Private Limited 3 patentsANDA 220197relugolix | D. Del. | 2025-03-19 | Active | — |
Sumitomo Pharma Switzerland GmbH et al v. Hetero Labs Limited et al 3 patentsANDA 220143relugolix | D. Del. | 2025-03-19 | Active | — |
Sumitomo Pharma Switzerland GmbH, et al. v. MSN Laboratories Private Limited, et al. 2 patentsANDA 220287relugolix | D. Del. | 2025-03-19 | Active | — |
Sumitomo Pharma Switzerland GmbH et al v. Cipla Limited et al 3 patentsANDA 220080relugolix | D. Del. | 2025-03-13 | Active | — |
Sumitomo Pharma Switzerland GmbH et al v. Apotex Inc. et al 3 patentsANDA 219793relugolix | D. Del. | 2025-03-12 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sumitomo Pharma America, Inc. FDA-2026-P-2079 Sumitomo Pharma America, Inc. filed this citizen petition under 21 U.S.C. § 355(q) regarding NDA No. 214621 for ORGOVYX (relugolix) oral tablets, requesting that the FDA refuse approval of any relugolix ANDA that does not include labeling regarding the required six-hour dose separation and patient m | 505(q) | 2026-02-26 | Open | Sumitomo Pharma America |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7300935 | Jan 28, 2029 | — | Yes | — | — | — |
| 8058280 | Jan 28, 2026 | — | Yes | Yes | — | — |
| 10350170 | Feb 25, 2036 | — | — | Yes | — | — |
| 10449191 | Sep 29, 2037 | — | — | — | — | |
| 10786501 | Sep 29, 2037 | — | — | — | — | |
| 11583526 | Sep 29, 2037 | — | — | — | — | |
| 11795178 | Sep 27, 2033 | — | Yes | Yes | — | — |
| 12097198 | Sep 29, 2037 | — | — | — | — | |
| 12144809 | Sep 29, 2037 | — | — | — | — | |
| 12325714 | Sep 27, 2033 | — | Yes | Yes | — | — |
| 12336990 | Sep 29, 2037 | — | — | — | — | |
| 12629370 | Sep 29, 2037 | — | — | — | — |
Sumitomo Pharma added U.S. Patent 12,629,370 to the Orange Book for Orgovyx (relugolix) NDA 214621.
New: New record